Endometrial Malignancy in Breast Cancer Patients With or Without AUB

NCT05977829 | Completed

• 1 other identifier: 691
• Study Type: observational
• Target: 283
• Locations: 1 country
• Sites: 1

Brief Summary

In order to assess the hysteroscopic, histopathologic, and ultrasonographic aspects of uterine monitoring in postmenopausal breast cancer patients with or without abnormal uterine bleeding (AUB), as well as to calculate the risk of endometrial cancer in women with or without AUB.

Conditions

Endometrial Neoplasms

Outcome Measures

Primary Outcomes (2)

• Endometrial cancer rate

  1 month after admission

• Endometrial hyperplasia rate

  1 month after admission

Study Arms (2)

Breast cancer patients with abnormal uterine bleeding

* Transvaginal ultrasonography * Outpatient Hysteroscopy

Diagnostic Test: Ultrasound; Diagnostic Test: Hysteroscopy

Breast cancer patients without abnormal uterine bleeding

* Transvaginal ultrasonography * Outpatient Hysteroscopy

Diagnostic Test: Ultrasound; Diagnostic Test: Hysteroscopy

Interventions

Ultrasound DIAGNOSTIC_TEST

Transvaginal ultrasound to carry out uterine surveillance

Breast cancer patients with abnormal uterine bleeding; Breast cancer patients without abnormal uterine bleeding

Hysteroscopy DIAGNOSTIC_TEST

Outpatient hysteroscopy to carry out uterine surveillance

Breast cancer patients with abnormal uterine bleeding; Breast cancer patients without abnormal uterine bleeding

Eligibility Criteria

• Age: 43 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing gynecological examinations for endometrial surveillance related to selective estrogen receptor modulators, aromatase inhibitors or other hormone therapy for breast cancer

You may qualify if:

• In case of AUB: ultrasonographic endometrial thickness \>5 mm at transvaginal ultrasound
• In case of non-AUB group ultrasonographic suspicion of endometrial or myometrial abnormalities

You may not qualify if:

• severe comorbidities (cardiovascular, metabolic, endocrine, and immunological disorders)
• receiving any other form of pharmacologic therapy

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

University of Cagliari

Cagliari, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Endometrial biopsy for histopathological analysis.

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Ultrasonography; Hysteroscopy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Gaetano Riemma, MD

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

• Pasquale De Franciscis, MD PhD

  University of Campania Luigi Vanvitelli

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 4, 2023
• Study Start: January 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: July 30, 2022
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

IT (1)